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Clinical validity o...
Clinical validity of second-generation tau PET tracers as biomarkers for Alzheimer’s disease in the context of a structured 5-phase development framework
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- Bischof, Gérard N. (author)
- University Hospital of Cologne
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- Dodich, Alessandra (author)
- University of Trento,University of Geneva
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- Boccardi, Marina (author)
- German Center for Neurodegenerative Diseases (DZNE), Bonn
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- van Eimeren, Thilo (author)
- German Center for Neurodegenerative Diseases (DZNE), Bonn,University Hospital of Cologne
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- Festari, Cristina (author)
- Centro San Giovanni di Dio Fatebenefratelli
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- Barthel, Henryk (author)
- Leipzig University
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- Hansson, Oskar (author)
- Lund University,Lunds universitet,Klinisk minnesforskning,Forskargrupper vid Lunds universitet,Clinical Memory Research,Lund University Research Groups,Skåne University Hospital
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- Nordberg, Agneta (author)
- Karolinska Institutet,Karolinska Institute
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- Ossenkoppele, Rik (author)
- Lund University,Lunds universitet,Klinisk minnesforskning,Forskargrupper vid Lunds universitet,Clinical Memory Research,Lund University Research Groups,Vrije Universiteit Amsterdam
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- Sabri, Osama (author)
- Leipzig University
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- Giovanni, B. Frisoni G. (author)
- University of Geneva,Geneva University Hospital
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- Garibotto, Valentina (author)
- University of Geneva,Geneva University Hospital
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- Drzezga, Alexander (author)
- University Hospital of Cologne,German Center for Neurodegenerative Diseases (DZNE), Bonn
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(creator_code:org_t)
- 2021-02-16
- 2021
- English 11 s.
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In: European Journal of Nuclear Medicine and Molecular Imaging. - : Springer Science and Business Media LLC. - 1619-7070 .- 1619-7089. ; 48:7, s. 2110-2120
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Abstract
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- Purpose: In 2017, the Geneva Alzheimer’s disease (AD) strategic biomarker roadmap initiative proposed a framework of the systematic validation AD biomarkers to harmonize and accelerate their development and implementation in clinical practice. Here, we use this framework to examine the translatability of the second-generation tau PET tracers into the clinical context. Methods: All available literature was systematically searched based on a set of search terms that related independently to analytic validity (phases 1–2), clinical validity (phase 3–4), and clinical utility (phase 5). The progress on each of the phases was determined based on scientific criteria applied for each phase and coded as fully, partially, preliminary achieved or not achieved at all. Results: The validation of the second-generation tau PET tracers has successfully passed the analytical phase 1 of the strategic biomarker roadmap. Assay definition studies showed evidence on the superiority over first-generation tau PET tracers in terms of off-target binding. Studies have partially achieved the primary aim of the analytical validity stage (phase 2), and preliminary evidence has been provided for the assessment of covariates on PET signal retention. Studies investigating of the clinical validity in phases 3, 4, and 5 are still underway. Conclusion: The current literature provides overall preliminary evidence on the establishment of the second-generation tau PET tracers into the clinical context, thereby successfully addressing some methodological issues from the tau PET tracer of the first generation. Nevertheless, bigger cohort studies, longitudinal follow-up, and examination of diverse disease population are still needed to gauge their clinical validity.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Neurosciences (hsv//eng)
Keyword
- Alzheimer’s disease
- Biomarker-based diagnosis
- Second-generation tau PET tracers
- Strategic roadmap
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- ref (subject category)
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- By the author/editor
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Bischof, Gérard ...
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Dodich, Alessand ...
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Boccardi, Marina
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van Eimeren, Thi ...
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Festari, Cristin ...
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Barthel, Henryk
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show more...
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Hansson, Oskar
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Nordberg, Agneta
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Ossenkoppele, Ri ...
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Sabri, Osama
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Giovanni, B. Fri ...
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Garibotto, Valen ...
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Drzezga, Alexand ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Neurosciences
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European Journal ...
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Lund University
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Karolinska Institutet